MAUDE Adverse Event Report: KARL STORZ ENDOVISION HOPKINS TELESCOPE 0°, 5 MM, 29 CM

Model Number	R26046AA
Medical Device Problem Codes	Break (1069); Chemical Problem (2893); Material Deformation (2976); Optical Distortion (3000)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported that there was a cloudy image.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device was returned on june 12, 2025 and will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id_(b)(4).
Additional Manufacturer Narrative
Result of investigation: the customer's statement "there was a cloudy image" can be confirmed.The imaging of the 26046aa - hopkins telescope 0°, 5 mm, 29 cm (serial number (b)(6)) shows a displaced lens system with several flakes/breaks in the individual sections.The eyepiece shell is torn from the edge to the proximal cover glass.The system shaft is clearly bent.Clear impact marks are visible in the distal area of the optics.The distal solder seam is chemically corroded and shows a crack.Residues and splinters are visible throughout the system.The optics were exposed to enormous mechanical force, possibly caused by damage from a fall.The damage found is not due to a manufacturing/production defect.No further action will be taken.The above conducted investigations did not reveal a root cause related to the labelling, the device or its history.All production related quality checks were passed and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pick up in similar complaints, no trend was identified.This event is filed under internal complaint id (b)(4).

• Brand Name: HOPKINS TELESCOPE 0°, 5 MM, 29 CM
• Common Device Name: HOPKINS TELESCOPE 0°, 5 MM, 29 CM
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton, ma 01507 ; GM 01507
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 22126505
• Report Number: 9610617-2025-00959
• Device Sequence Number: 15308945
• Product Code: GCJ
• UDI-Device Identifier: 04048551092088
• UDI-Public: 04048551092088
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K935279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: R26046AA
• Device Catalogue Number: R26046AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 06/12/2025; 11/24/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/16/2025; 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown